GroundRules
21 CFR 876.4530: Gastroenterology-urology fiberoptic retractor.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
- Subpart E—Surgical Devices
(a) Identification. A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Collected 2026-08-27T02:24:47Z. Source file · JSON